Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405373
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-05-06
Brief Title:
Behavioral Approaches to Reduce Diabetes Distress in Adults With Type 1 Diabetes A Pragmatic SMART
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Fusing Rapid-cycle Testing and Adaptive Trial Designs A Scientific Pipeline to Translate and Individualize Evidence-based Psychosocial and Behavioral Interventions in Routine Type 1 Diabetes Care
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ChargeUp
Brief Summary:
This study is designed to compare two behavioral approaches to reduce diabetes distress the expected burdens concerns fears and threats that arise from the challenges of living with diabetes in adults with type 1 diabetes At the study baseline participants will be randomized to take part in one of two virtual group-based interventions the Primary intervention utilizing either an emotions-focused or a problem-solving approach to reduce diabetes distress After the initial intervention participants will complete surveys to assess their response to the material Participants who are determined to be non-responders ie the Primary intervention was not effective will be re-randomized to one of two Supplementary interventions which will include individualized sessions to learn andor practice strategies related to either the psychological or problem-solving approach
Detailed Description:
The study will compare the effectiveness of an emotions-focused approach with a problem-solving based approach to reduce diabetes distress DD The investigators will enroll N200 adults 30 years and older with type 1 diabetes T1D and elevated DD from a single clinical site to participate in a 12-week study All interventions and assessments will be delivered in a pragmatic and entirely virtual format The investigators will utilize a precision medicine trial design Sequential Multiple Assignment Randomized Trial SMART to compare two evidence-based virtual group interventions to reduce DD in adults with T1D primary aim The secondary aims of the study are to estimate next best steps for participants who do not respond to group-based interventions and to estimate optimal treatments or sequences of treatments for different individuals based on their individual characteristics including response to prior treatment
The study includes an initial randomization to one of two 5-week Primary Interventions ReCharge an Acceptance and Commitment Therapy ACT-focused approach that will help to reduce the emotional burden of diabetes management or TakeCharge a problem-solving focused approach that will equip participants with new skills to manage type 1 diabetes Participants will complete a series of assessments to determine their response to the Primary Intervention Participants who did not respond to the Primary Intervention will be re-randomized to participate in one of two Supplementary Interventions over a 5-week period where they will have three virtual individualized sessions for exposure and practice with either the ReCharge or TakeCharge curriculum
The investigators will evaluate the Reach Effectiveness Adoption Implementation and Maintenance of all phases of the study By collecting both quantitative data and key qualitative feedback from providers and participants the investigators will be able to assess and improve the pragmatic design of these evidence-based interventions for routine integration into healthcare settings Completion of primary and secondary aims will inform a future program which saves resources and expands the availability of guidelines-oriented care to all patients with T1D
The study includes an initial randomization to one of two 5-week Primary Interventions ReCharge an Acceptance and Commitment Therapy ACT-focused approach that will help to reduce the emotional burden of diabetes management or TakeCharge a problem-solving focused approach that will equip participants with new skills to manage type 1 diabetes Participants will complete a series of assessments to determine their response to the Primary Intervention Participants who did not respond to the Primary Intervention will be re-randomized to participate in one of two Supplementary Interventions over a 5-week period where they will have three virtual individualized sessions for exposure and practice with either the ReCharge or TakeCharge curriculum
The investigators will evaluate the Reach Effectiveness Adoption Implementation and Maintenance of all phases of the study By collecting both quantitative data and key qualitative feedback from providers and participants the investigators will be able to assess and improve the pragmatic design of these evidence-based interventions for routine integration into healthcare settings Completion of primary and secondary aims will inform a future program which saves resources and expands the availability of guidelines-oriented care to all patients with T1D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12-22-ACE-18 | OTHER_GRANT | American Diabetes Association | None |